Stents are tubular prostheses designed for implantation in a vessel to maintain patency of the vessel lumen. Stents are used in various vessels throughout the body, including the coronary arteries, femoral arteries, iliac arteries, renal artery, carotid artery, vascular grafts, biliary ducts, trachea, and urethra, to name some examples. Stents are typically implanted by means of long and flexible delivery catheters that carry the stents in a compact, collapsed shape to the treatment site and then deploy the stents into the vessel. In some applications, balloon expandable stents are used. These stents are made of a malleable metal such as stainless steel or cobalt chromium and are expanded by means of a balloon on the tip of the delivery catheter to plastically deform the stent into contact with the vessel wall. In other applications, self-expanding stents are used. These are made of a resilient material that can be collapsed into a compact shape for delivery via catheter and that will self-expand into contact with the vessel when deployed from the catheter. Materials commonly used for self-expanding stents include stainless steel and elastic or superelastic alloys such as nickel titanium (Nitinol™).
While self-expanding stents have demonstrated promise in various applications, such stents face a number of challenges. One such challenge is that in some cases the disease in a vessel may be so extensive that a stent of very long length, e.g. 30-200 mm, is called for. Currently available stents are typically less than 30 mm in length, and suffer from excessive stiffness if made longer. Such stiffness is particularly problematic in peripheral vessels such as the femoral arteries, where limb movement requires a high degree of flexibility in any stent implanted in such vessels.
To overcome the stiffness problem, the idea of deploying multiple shorter stents end-to-end has been proposed. However, this approach has suffered from several drawbacks. First, currently available delivery catheters are capable of delivering only a single stent per catheter. In order to place multiple stents, multiple catheters must be inserted, removed and exchanged, heightening risks, lengthening procedure time, raising costs, and causing excessive material waste. In addition, the deployment of multiple stents end-to-end suffers from the inability to accurately control stent placement and the spacing between stents. This results in overlap of adjacent stents and/or excessive space between stents, which is thought to lead to complications such as restenosis, the renarrowing of a vessel following stent placement. With self-expanding stents the problem is particularly acute because as the stent is released from the catheter, its resiliency tends to cause it to eject or “watermelon seed” distally from the catheter tip by an unpredictable distance. During such deployment, the stent may displace not only axially but rotationally relative to the delivery catheter resulting in inaccurate, uncontrollable, and unpredictable stent placement.
Interleaving stents or stent segments such as those disclosed in co-pending application Ser. No. 10/738,666, filed Dec. 16, 2003, which is incorporated herein by reference, present even greater challenges to conventional delivery systems. Interleaving stents have axially extending elements on each end of the stent that interleave with similar structures on an adjacent stent. Such interleaving minimizes the gap between adjacent stents and increases vessel wall coverage to ensure adequate scaffolding and minimize protrusion of plaque from the vessel wall. However, such interleaving requires that the relative rotational as well as axial positions of the adjacent stents be maintained during deployment to avoid metal overlap and excessive gaps between stents. Conventional delivery systems suffer from the inability to control both the axial and rotational positions of self-expanding stents as they are deployed.
What are needed, therefore, are stents and stent delivery system that overcome the foregoing problems. In particular, the stents and stent delivery systems should facilitate stenting of long vascular regions of various lengths without requiring the use of multiple catheters. Such stents and delivery systems should also provide sufficient flexibility for use in peripheral vessels and other regions where long and highly flexible stents might be required. In addition, the stents and stent delivery systems should enable the delivery of multiple stents of various lengths to one or more treatment sites using a single catheter without requiring catheter exchanges. Further, the stents and stent delivery systems should facilitate accurate and repeatable control of stent placement and inter-stent spacing to enable deployment of multiple self-expanding stents end-to-end in a vessel at generally constant spacing and without overlap. Moreover, the stents and delivery systems should enable the deployment of interleaving stents or stent segments with precision and control over both the axial spacing and rotational position of each stent or segment.